An Iodine Balance Experiment

Iodine Deficiency Clinical Trial

Official title:

Exploration of the Appropriate Recommended Nutrient Intake of Iodine in Chinese Euthyroid Women: an Iodine Balance Experiment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03279315
• Other study ID #: NSFC-31340033
• Status: Completed
• Phase: N/A
• First received: September 7, 2017
• Last updated: September 8, 2017
• Start date: November 20, 2014
• Est. completion date: March 10, 2017

Study information

• Verified date: September 2017
• Source: Tianjin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different periods. The total iodine intake from diet, water and air as well as the total iodine excretion by urine, faces and respiration were monitored and determined, and a total of 300 samples were collected. The sweat iodine loss was also considered. Moreover, the regression curve model between the 24-h iodine intake and 24-h iodine excretion was also established.

Description:

The experiment was conducted between November and December with a total duration of 1 month. Referring to the experience from Harrison and Dworkin, however, considering the negative iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week. The total daily iodine intake consisted of dietary iodine intake, water iodine intake and iodine from breathing, while iodine could be excreted out of human body by urine, faces, sweat and breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each individual participant, and the iodine balance was calculated accordingly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 10, 2017
• Est. primary completion date: December 19, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 25 Years

Eligibility

Inclusion Criteria:

• The ones with normal thyroid function, urinary iodine concentration, agree with the experiment.

Exclusion Criteria:

• The ones with abnormal thyroid hormone level, urinary iodine concentration (UIC) or autoantibody-positive were excluded from the study.

Related Conditions & MeSH terms

• Iodine Deficiency
• Nutritional Requirements

Intervention

Dietary Supplement:
• iodized table salt, non-iodized table salt
During the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total iodine intake and total iodine excretion	Iodine intake includes iodine from food, water and air (µg/d).	12 days
Primary	Total iodine excretion	Iodine excretion includes iodine excreted by urine, feces, sweat and breath (µg/d).	12 days
Primary	urinary iodine concentration (UIC)	µg/L	At the beginning of the experiment
Primary	Thyroid function	FT3 (pmol/L), FT4 (pmol/L),TSH (mIU/L), TG (ng/mL), TGAb (IU/mL), TPOAb (IU/mL)	At the beginning of the experiment